Tibotec Pharmaceuticals and Gilead Sciences inked a license agreement to develop and commercialize a once-daily, single-tablet combination HIV-1 product comprising a fixed dose of Tibotec’s protease inhibitor Prezista® (darunavir) and Gilead’s investigational pharmacoenhancer, cobicistat. Prezista is currently approved in markets including the U.S. and Europe as combination therapy with ritonavir for treatment-naive and treatment-experienced adult HIV-1 patients. Cobicistat is in Phase III development.

Under terms of the licensing agreement, Tibotec will be responsible for the formulation, manufacture, registration, distribution, and commercialization of the Prezista/cobicistat fixed-dose combination worldwide. Gilead retains rights to manufacture, develop, and commercialize cobicistat as a standalone product and in combination with other agents.

The Prezista/cobicistat deal is contingent on the firms completing negotiations for another deal centered on development and commercialization of a future single-tablet regimen (STR) combining Prezista with Gilead’s Emtriva® (emtricitabine) and its investigational agents cobicistat and GS 7340, an NRTI. Under this deal Gilead would be responsible for development and commercialization of the STR worldwide.

Gilead’s marketed combination HIV therapy Atripla® (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) achieved sales of $744.5 million in the first quarter of 2011, up 7% on sales in the equivalent quarter in 2010. Sales of Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) were $673.1 million, up from $657.8 million. Sales of Viread® (tenofovir disoproxil fumarate) for the treatment of HIV and chronic HBV were $168.4 million.

Tibotec’s marketed HIV drugs include Prezista, and the NNRTIs Etravirine and Rilpivirine (TMC278). Rilpivirine was granted FDA approval just last month.

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